Sunday, August 14, 2016

EPA Whitewashes Illegal Human Experiments

The U.S. Environmental Protection Agency (EPA) has employed the prestigious National Academy of Sciences to whitewash the EPA's illegal experiments on human beings. Naturally, the sordid activity is all being conducted in secret.

Several years ago, we detailed for American Thinker readers how we had discovered that the EPA was violating virtually every law enacted and regulation promulgated for the protection of human experiments since the development of the Nuremberg Code.

The story begins in the 1990s, when the EPA began regulating fine particulate matter (P.M.) in outdoor air. These regulations were justified on the basis that they would prevent 15,000 premature deaths per year. The supposedly scientific studies underlying the rules could not be challenged at the time because the EPA refused to provide Congress and independent researchers with the key underlying data. Also, the relevant laws and their judicial interpretation did not provide a way to challenge EPA science in court.

Though the EPA got away with issuing the rules, it knew they were vulnerable to challenge because the underlying studies – all dubious statistical correlation studies – didn't actually show that P.M. killed anyone. Neither did animal toxicology studies, no matter how much P.M. the laboratory animals inhaled. So the EPA decided to back up its statistical claims by testing extremely high doses of P.M. on real, live people.

Over the next 15 years, the EPA began quietly experimenting on elderly subjects (up to age 80), asthmatics, people with heart disease or metabolic syndrome, and combinations of the aforesaid by placing them in a sealed chamber and making them inhale high levels of P.M. as well as diesel exhaust, smog, and even chlorine gas. At one point, the EPA even experimented with children by spraying high levels of diesel exhaust particulate up their noses.

Though none of these experiments produced any biological response indicating that P.M. is in any way harmful, the EPA relied on its statistical studies to make even more grandiose claims about the supposed dangers of P.M. The EPA claimed that any inhalation of P.M. could cause death. It claimed that death could occur within hours of inhalation or after decades of inhalation. In 2011, EPA administrator Lisa Jackson testified to Congress than P.M. caused about 570,000 deaths per year in the U.S., more than 20 percent of all U.S. deaths.

The EPA continued its experiments.

We found out about the experiments in September 2011, when the EPA finally published a report about an alleged health effect caused by P.M. Agency researchers exposed an obese 58-year-old woman with heart disease to a high level of P.M. The experiment was stopped when the woman's heart began to beat irregularly. She was taken to the hospital, where she remained overnight. The EPA's report chalked up the event to the exposure to P.M.

Although the EPA's conclusion was obviously faulty (the woman had a pre-existing heart condition that caused the arrhythmia) and has since been debunked by other research, the report led us to inquire about how exactly the woman came to be exposed to high P.M. by EPA researchers.

After several Freedom of Information Act requests and pressure from Congress, we learned that although the EPA had declared P.M. essentially the most deadly substance known to man, the agency was intentionally exposing individuals it thought would be most vulnerable to the effects of P.M. in order to support its statistical claims about P.M. lethality and its regulations.

The problem for the EPA is that if P.M. is as deadly as the agency claims, then these experiments are fundamentally unethical and illegal. Humans cannot be treated as guinea pigs for the purpose of advancing a regulatory agenda. Compounding the illegality of the experiments is the fact that the EPA never informed the study subjects that it believed that the experiments could kill them. This conduct violated federal and state laws requiring that physicians and researchers obtain informed consent prior to experimenting on humans – not that anyone could actually consent to illegal experiments in the first place.

(Read the snippets we excerpted out of the FDA antipsychotic drug labels, and don't bother with the FDA links. They got house cleaned shortly after we called them on it.)

(Though the mechanism of action is unknown, . . .)

After a federal lawsuit and much bad press, the EPA inspector general (I.G.) took up the case in October 2012. Eighteen months later, the I.G. concluded that the agency had indeed failed to warn study subjects that it believed that the experiments could kill them while inexplicably ignoring the issue of whether the experiments were fundamentally illegal and unethical. No matter, though. Media reports of the I.G.'s limited finding tremendously embarrassed the agency – so much, in fact, that something had to be done.

Enter the National Academy of Sciences (NAS).

The NAS was formed in 1863 by Congress and President Lincoln to advise the government on science. It has a bifurcated structure. The actual NAS has evolved into an honorary membership organization for elite and politically well connected scientists. The actual advice-giving part of the NAS is a separate non-profit organization called the National Research Council (NRC), which hires itself out to federal agencies to provide scientific advice. In providing that advice, however, the NRC does not rely on the prestigious NAS membership. Instead, it enlists second- and third-tier (or worse) scientists eager to build their résumés and improve their standing in academia. Despite the decidedly hack nature of NRC advice, it is marketed as if it were coming from the collective wisdom of the prestigious NAS membership.

After the embarrassing I.G. report was issued, the EPA decided to avail itself of the benefit of the NAS-NRC charade. Not only did it hope to whitewash the I.G. report, but it was hoping to conduct the process in secret. It almost worked.

We were notified about what was going on by a source who only inadvertently learned of the EPA-NAS scheme near the end of the process. From what we have learned so far, it looks as though the EPA contracted with the NAS-NRC in early 2015. A committee of mostly academics was formed and began meeting on June 1, 2015. There was no public notice of the formation of the committee, and though the meeting was supposed to be open to the public, there was no public notice. So the "public" meeting was attended only by the committee members, NRC staff, and the EPA. Four more meetings were held, the last one in April 2016. None open to the public.

When we learned of the NRC committee in June 2016, we hurriedly provided comments to the committee docket and requested the opportunity to present information to the committee – a reasonable request, given the circumstances. We were the ones who had discovered and exposed the EPA's wrongdoing. We are the ones most familiar with the facts. Based on a review of the committee docket, it was clear that the EPA had provided the committee with selective, misleading, and incomplete information. Two months later, we are still waiting for the NRC to respond to our request.

In the end, this entire sordid episode raises two main issues. First, to whom is the EPA lying? If P.M. is really as dangerous as the EPA claims, which claims it uses for its regulations, then the agency has committed felonious acts against its human guinea pigs. The only way the EPA has not committed these crimes is if P.M. is not as dangerous as the EPA claims, in which case the agency has lied to the public and Congress and has grossly overregulated P.M.

There is no third possibility here. The EPA has seriously lied to someone.

The other issue is one for the NAS as an organization. The prestigious group is being used in a covert effort to whitewash the EPA's dishonest and illegal conduct – a far cry from its chartered mission and probably what its elite scientist members expect or would support. Now that the scheme has been uncovered, it should think twice before it self-immolates doing the EPA's dirty work.

John Dunn, M.D., J.D. is an instructor in emergency medicine at Fort Hood, Texas and adviser to the American Council on Science and Health and the Heartland Institute. Steve Milloy, MHS, J.D., LLM publishes JunkScience.com and is a senior legal fellow at the Energy & Environment Law Institute.

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